Clearance Summary
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON received FDA 510(k) clearance under submission number K101334, sponsored by Pathway Medical Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-06-11.
- Submission: K101334
- Applicant / Sponsor: Pathway Medical Technologies, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 2010-06-11
Classification & Regulation
This clearance is catalogued under FDA product code MCW and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.